Kornimate/medical-research-clean huggingface dataset:
conform: rotational fractional resection for submental contouring

Conditions: Skin Laxity; Lipodystrophy

Summary: this study will evaluate the safety and efficacy of rotational fractional resection (rfr) to improve neck contouring. rfr is used to remove loose skin and fat.

this is a prospective, multi-center, single-arm (non-randomized), interventional cohort, non-significant risk (nsr) study designed to investigate the efficacy and safety of rotational fractional resection (skin resection and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. the total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. the follow-up period will be approximately 6 months after the procedure. eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.

Eligibility criteria:
inclusion criteria: * healthy male or female, at least 30 years old * moderate submental (neck) fat * mild to moderate submental (neck) skin laxity (loose skin) * willing and able to provide informed consent * willing and able to comply with all protocol requirements * willing to limit direct sun exposure and use sunscreen for duration of the study * agree to maintain weight for duration of the study * willing to have photographs taken that could identify the participant exclusion criteria: * previous intervention to treat submental fat or skin laxity * use of aspirin, ibuprofen, naproxen, or vitamin e within 14 days of the procedure * sensitivity to local anesthesia * severe acne, cystic acne or acne scars on neck * trauma of chin or neck area * skin infection or rash on neck * psoriasis, eczema, rosacea, or vitiligo * history of scarring * history or current symptoms of dysphagia * chronic or persistent coughing * body mass index (bmi) \> 30 * clinically significant bleeding disorder * anemia, kidney disease, or liver disease

Keywords: submental fullness submental fat loose skin
the dutch acute stroke trial (dust): prediction of outcome with computed tomography (ct) - perfusion and ct-angiography

Conditions: Acute Stroke

Summary: less than 10% of all ischemic stroke patients are treated by intravenous thrombolysis (ivt) as most present later than the accepted 3 hour time window. intra-arterial thrombolysis (iat) is possible 3-6 hours post ictus, but is infrequently used. mechanical thrombectomy (mt) with a merci device is a new intervention possibility but lacks large randomized studies. although it is desirable to treat more stroke patients, clinical information and plain ct alone are insufficient to discriminate which patients are most likely to benefit or be harmed from treatment. advanced imaging techniques can help predict patient outcome and provide the necessary information to weigh expected benefit against associated risk of treatment. visualizing the penumbra, the hypoperfused tissue at risk of infarction around the irreversible infarct core, is one way of identifying patients most likely to benefit from intervention. magnetic resonance imaging (mri) based selection of patients with sufficient penumbra for thrombolysis is possible, however, mr has less 24-hour availability than ct in the acute setting. plain ct is mostly used to exclude intracerebral hemorrhage, and can easily be extended with ct perfusion (ctp) and ct angiography (cta). ctp compares well to mri for imaging penumbra and infarct core, and it is faster and more feasible than mri. other image findings such as infarct core size and leakage of the blood-brain-barrier (permeability) on ctp, and site and extent of the occlusion and collateral circulation on cta also influence stroke outcome but have not been combined in one study to assess their combined predictive value. hypothesis: the investigators hypothesize that combined ctp and cta parameters can predict patient outcome in acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * acute neurological deficit caused by cerebral ischaemia * admission \< 9 hours after onset of neurological deficit * nih stroke scale (nihss) of at least 2 * no absolute contraindications against intravenous contrast * informed consent from patient or family after admission scan * patients who awaken with stroke symptoms can only be included if they went to sleep without any stroke symptoms and the time from going to sleep until imaging is less than 9 hours exclusion criteria: * neurological deficit caused by another diagnosis than cerebral ischaemia (such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor) * patients with known contrast allergy or kidney failure * patients with the known combination of renal insufficiency and heart failure (new york heart association (nyha) iv) will be excluded for the ctp and cta scan at 3 days; they will have a non-contrast ct (ncct) at that time.

Keywords: ct-perfusion ct-angiography
relative bioavailability study

Conditions: Healthy Volunteers

Summary: to investigate relative bioavailability of crushed tablets suspended in apple sauce or water


Eligibility criteria:
inclusion criteria: * healthy male subject * age: 18 to 45 years (inclusive) at the first screening examination * ethnicity: white * body mass index (bmi): \>18 and \<29.9 kg/m2 exclusion criteria: * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, or effects of the study drug will not be normal * history of coronary artery disease * symptomatic postural hypotension (e.g. dizziness, lightheadedness) * history of bronchial asthma or any other airway disease * smoking (former smokers who have stopped smoking at least 3 months before the first study drug administration may be included) * clinically relevant findings in the ecg such as a second- or third-degree atrioventricular block, prolongation of the qrs complex over 120 ms or of the qtc interval (qt interval corrected for heart rate) over 450 ms * systolic blood pressure below 100 or above 145 mmhg * diastolic blood pressure below 50 or above 95 mmhg * heart rate below 45 or above 95 beats per minute

Keywords: biological availability
reduction the duration of antibiotic therapy in the elderly (propage)

Conditions: Lung Infection

Summary: the main objective is to evaluate the interest of the repeated measurement of procalcitonin in patients with pulmonary infection to reduce the duration of antibiotic therapy in comparison with a conventional clinical strategy.


Eligibility criteria:
inclusion criteria: * age ≥ 80 years * started antibiotics for a chest infection * procalcitonin performed j0 antibiotic treatment * person affiliated to the social security exclusion criteria: * patients with a documented infection with germs after listeria spp, legionella pneumophilia, mycobacterium tuberculosis * patients with a documented infection with a virus or parasite (eg hemorrhagic fever, malaria) * patients with endovascular infection associated (endocarditis, pacemaker. intravascular catheter) * patients with lung abscess associated upon entry patients with a chronic infection associated * patients with severe immunosuppression (hiv or transplant) * palliative patient * death within 24 hours of admission to nursing units. * presence of antibiotic treatment for chronic infection. * patient under guardianship, curatorship or any other administrative or judicial action or deprivation of the right or freedom * patients hospitalized without their consent

Keywords: infection lung elderly patients
endocrine dysfunction and growth hormone deficiency in children with optic nerve hypoplasia

Conditions: Growth Hormone Deficiency; Septo-Optic Dysplasia; Hypopituitarism

Summary: hypotheses: 1. the prevalence of endocrinopathies, and growth hormone (gh) deficiency in particular, among young children diagnosed with optic nerve hypoplasia (onh) is higher than is commonly thought. 2. early treatment of children with onh and gh-deficiency can prevent adverse outcomes. aims: 1. determine the prevalence and types of endocrinopathies in children diagnosed with onh. 2. correlate endocrine outcome with radiographic, ocular, and developmental findings in children with onh. 3. examine the effect of gh treatment on growth and obesity in children with onh, gh-deficiency, and either subnormal or normal growth compared to children with onh that are not gh-deficient. 4. compare growth outcomes between children with isolated gh-deficiency and those with multiple hormone deficiencies.

subjects for this study will be recruited from active and newly enrolled subjects in our larger onh study. the study duration is three years and we anticipate 38 subjects will enroll. subjects will be recruited for this study if they present with either growth deceleration or at least one subnormal result for igf-1 or igfbp-3. baseline information collected includes: height, weight, head circumference, examinations by an endocrinologist and ophthalmologist, endocrine laboratory testing, fundus photography, electrophysiology testing, head mri, and a developmental assessment. a glucagon stimulation test will be performed and subjects who are deemed gh-deficient and who have delayed growth will be assigned to gh treatment, in line with standard clinical practice. those with normal growth but determined to be gh-deficient by a glucagon stimulation test will be randomized to treatment with gh vs control (no intervention; observation only). subjects assigned or randomized to treatment with gh will be provided with gh for the duration of their participation in the study. enrolled subjects will return every four months to monitor progress. subjects will undergo a physical examination at each visit, including height, weight, head circumference, and body fat. in addition, subjects assigned or randomized to growth hormone will have laboratory testing of thyroid, igf-1 and igfbp-3 hormones, and fasting lipid levels.

Eligibility criteria:
inclusion criteria: * new subjects diagnosed with onh less than or equal to 2 years of age and subjects actively enrolled (in currently approved prospective onh study) will be eligible for enrollment.

Keywords: optic nerve hypoplasia
evaluation of optical pumping magnetometer sensors for magnetoencephalography imaging

Conditions: Epilepsy

Summary: this research is a feasibility study on a new generation of brain magnetic activity sensor which should allow the development of this modality, until now limited by its cost to a few large university centers. the measurement of magnetic activity allows the detection and localization of abnormal activities such as paroxysmal events occurring between seizures in patients with epilepsy as well as research into brain function. it is the only one, along with eeg and related techniques, to provide data related to the speed of the brain. meg, by virtue of the properties of magnetic fields, has a greater potential than eeg for the detection and localization of the neuronal sources which cause it. the meg sensors used until now use superconducting quantum interference devices (squid) components that are extremely sensitive but require complex instrumentation and only operate under superconducting conditions, resulting in prohibitive maintenance and cost. the alternative could come from a new magnetic activity sensor: the optical pumping magnetometers of the alkaline type. this preliminary study proposes to compare squid sensors with mpo he4 sensors for their ability to detect abnormal activities recorded in epileptic patients. measurements that cannot be recorded simultaneously two types of measurement will be compared with the reference that constitutes in-depth recording (stereotactic-eeg or seeg) used to precisely define the region of the brain to be resected in order to cure epileptic patients of their seizures. the expected results are a capacity of this type of sensors to detect epileptic activities equivalent to that of squids.


Eligibility criteria:
inclusion criteria: * adult patient (≥ 18 years old) * patient with drug-resistant focal epilepsy, undergoing seeg exploration * healthy subject, devoid of central neurological pathology, major ((≥ 18 years) * patient or healthy subject capable of giving informed consent for the study exclusion criteria: * meg "incompatible" healthy patients or volunteers. * wearers of prosthesis or pacemaker likely to generate artefacts interfering with the measurement. there is no danger to the subject, but the measurement itself may be impossible. * patients or healthy volunteers who cannot stand standing still for a few minutes. * pregnant or breastfeeding women * adults under guardianship or under legal protection * people deprived of their liberty * people who have not signed the informed consent
a phase 2 dose ranging, evaluator-blinded study to evaluate the safety of topical idp-118

Conditions: Plaque Psoriasis

Summary: subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.

approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined as at least of 10 % - 20% treatable body surface area (bsa) and an investigator's global evaluation (ige) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.

Eligibility criteria:
inclusion criteria: * male or female of any race, 18 to 65 (inclusive) years of age. * freely given verbal and written informed consent obtained from the subject. * clinical diagnosis of psoriasis at the screening and baseline visits with * at least 10% - 20% of total treatable bsa involvement, and * an investigator's global evaluation score of 3 or 4 ( moderate or severe) on a scale of 0 to 5 * good general health as determined by the investigator based on the subject's medical history and physical examination, with screening hematology, serum chemistry, and urinalysis laboratory values within normal range limits. exclusion criteria: * presence of psoriasis that was previously treated with prescription medication prior to the screening visit and is non-responsive to corticosteroid treatment, as determined by the investigator. * presence of any concurrent skin condition that could interfere with the evaluation of the study drug, as determined by the investigator. * history of adrenal disease * female who is pregnant, nursing an infant, or planning a pregnancy during the study period.

Keywords: psoriasis
effectiveness of nano-silver fluoride and silver diamine fluoride for arresting early childhood caries

Conditions: Early Childhood Caries

Summary: aim of the study: to evaluate and compare the clinical cariostatic efficacy of nsf with 38% sdf solution after sex and twelve months in arresting ecc lesions. the null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ecc.


Eligibility criteria:
inclusion criteria: * children younger than 4 years old. * the presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the international detection and assessment system- icdas ii) * completion of an informed consent to participate in the study. exclusion criteria: * children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility. * parental refusal to participate in the study. * allergy or sensitivity to silver or any of the materials included in the study.

Keywords: caries arrest, early childhood caries, nanosilver fluoride
peep and v/q mismatch in premature infants

Conditions: Respiratory Insufficiency Syndrome of Newborn; Infant, Premature, Diseases

Summary: positive end-expiratory pressure (peep) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. when ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. this study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of v/q mismatch to changes in the amount (or level) of peep.


Eligibility criteria:
inclusion criteria: 1. preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission 2. birth weight less than 1500 grams, as measured by the clinical team at neonatal admission. 3. presence of endotracheal intubation and invasive mechanical ventilation 4. less than or equal to 28 days chronologic age 5. supplemental oxygen requirement, with a fraction of inspired oxygen (fio2) equal to or greater than 0.25 as documented on the bedside infant flow sheet. exclusion criteria: 1. congenital anomalies, as determined by the clinical supervising physician 2. current of prior air leak syndrome, as determined by the clinical supervising physician. 3. non-english speaking parents 4. non-viable birth, as determined by the clinical supervising physician

Keywords: positive end-expiratory pressure peep bronchopulmonary dysplasia ventilator induced lung injury v/q mismatch
kidpower camp - structured games or playgroup

Conditions: Anxiety Disorders

Summary: clinically significant anxiety affects 20% of preschoolers and can become chronic, leading to depression, substance abuse, school-drop out and even suicide. to reduce anxiety and prevent its sequelae, clinically affected children must be effectively treated early. available interventions for clinically anxious preschoolers are effective for some, but not all children, with as many as 50% of 4-7 year olds continuing to meet criteria for an anxiety disorder after treatment. this trial aims to help learn how camp kidpower, trainings using either structured games or a playgroup, may lower anxiety in preschool age children. playing these games and learning that kids can do it, can teach kids how to keep going when they are feeling anxious. to find out if kidpower works by helping kids stay in charge of their behaviors and emotions, the study will look at parts of the brain as well as behaviors related to effortful control and fear, before and after training. the study hypothesizes that kidpower will produce greater increases in error-related negativity (ern), interchannel phase synchrony (icps) and effortful control (ec) behaviors than in the playgroup control.


Eligibility criteria:
inclusion criteria: 1. children between ages 4 -5.99 years at time of consent 2. children that have a primary clinical diagnosis of separation anxiety disorder, social anxiety disorder, generalized anxiety disorder, panic disorder, and/or obsessive-compulsive disorder 3. written informed consent by a parent/legal guardian and verbal assent from participant 4. fluent in english exclusion criteria: 1. history of head injury 2. history of serious medical or neurological illness 3. history of post-traumatic stress disorder (ptsd) 4. history of major depressive disorder (mdd) 5. current psychotherapy or behavioral interventions 6. history of neurodevelopmental delay, autism spectrum disorder (asd), or intellectual disability 7. currently taking medications that affect central nervous system functioning 8. primary clinical diagnosis is selective mutism or specific phobia 9. recent history of physically aggressive behaviors that have caused harm to other children 10. sibling of a child who has participated or is currently participating in this protocol

Keywords: effortful control preschool error-related negativity
immunogenicity and safety of group a, c, y and w135 meningococcal polysaccharide vaccine

Conditions: Meningitis

Summary: the purpose of this double-blind study is to evaluate the safety, reactogenicity and immunogenicity of group a,c,y and w135 meningococcal polysaccharide vaccine in 2 to 30 years-old children and adults. all subjects will receive 1 dose of group a,c,y and w135 meningococcal polysaccharide vaccine.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * healthy permanent residence 2-30 years old. * subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures. * axillary temperature ≤37.0 ℃. exclusion criteria: * history of meningitis infection or vaccination of meningococcal vaccine within the past 6 months. * allergic history or any sae after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia. * patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial. * receipt of blood or blood-derived products in the 3 months preceding vaccination. * participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination. * receipt of any live virus vaccine in the 15 days preceding vaccination. * receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination. * febrile illness (temperature ≥ 38°c) in the 3 days or any acute illness/infection in the 7 days preceding vaccination. * thrombocytopenia. * history of thyroid gland excision or treatment for thyroid gland disease in last 12 months. * functional or anatomic asplenia. * history of eclampsia, epilepsy, encephalopathy and mental disease or family disease. * chronic disease (such as down syndrome, diabetes, sickle cell anemia or neurologic disease, guillain-barre syndrome). * known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, hiv infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc. * in pregnancy or lactation or pregnant women during the test plan * any condition that, in the judgment of investigator, may affect trial assessment.

Keywords: safety, immunogenicity, meningococcal polysaccharide vaccine